Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118677
Status:
COMPLETED
Last Update Posted:
2007-08-30
First Post:
2005-07-01
Brief Title:
Long-Term Supervised Treatment Interruption in HIV-Infected Patients
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Long-Term Supervised Treatment Interruption in HIV-Infected Patients Who Started Antiretroviral Treatment With CD4 Over 350mm3 and Plasma HIV RNA Below 50 000mL ANRS 116 Trial SALTO
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is aimed at studying the safety of long term supervised treatment interruption in HIV infected patients with CD4 over 350mm3 and plasma HIV RNA under 50 000mL Another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption
Detailed Description:
The limitations of the drugs used against HIV include their toxicity their tolerability their propensity to induce resistance when not taken with absolute regularity and their cost Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart
In patients with high CD4 cell counts patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines we evaluated the safety of long term supervised treatment interruption Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption proviral HIV DNA at baseline and during follow-up plasma HIV RNA at baseline and during follow-up CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months
In patients with high CD4 cell counts patients receiving treatment of chronic infection with controlled viremia and patients who are receiving HAART now in whom treatment would not have been started based on current guidelines we evaluated the safety of long term supervised treatment interruption Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption proviral HIV DNA at baseline and during follow-up plasma HIV RNA at baseline and during follow-up CD4 T cell and CD8 T cell HIV specific responses at baseline and after 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None